| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | COBAS KRAS MUTATION TEST |
|---|
| Generic Name | Somatic gene mutation detection system |
|---|
| Applicant | Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722 |
|---|
| PMA Number | P140023 |
|---|
| Supplement Number | S004 |
|---|
| Date Received | 02/29/2016 |
|---|
| Decision Date | 09/24/2016 |
|---|
| Product Code |
OWD |
| Advisory Committee |
Pathology |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection. |
|
|
